Phase 4 N=110 Randomized Triple-blind Treatment

Assessing Neuropsychiatric Symptoms Including Depression, Anxiety, Irritability, and Suicidal Thoughts or Behavior in Subjects Quitting Smoking on Varenicline Tartrate or Placebo

Smoking Cessation

Bottom Line

View on ClinicalTrials.gov: NCT00749944 ↗

Enrolled (actual)

110

Serious AEs

0.0%

Results posted

Aug 2010

Primary outcome: Primary: Change From Baseline in the Profile of Mood States (POMS): Total Mood Disturbance (TMD) — 0.06; -0.66; 0.30; -0.17 scores on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: varenicline (Drug); placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Jul 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in the Profile of Mood States (POMS): Total Mood Disturbance (TMD)	0.06; -0.66; 0.30; -0.17; 0.95; 0.03	—
PRIMARY Change From Baseline in the Profile of Mood States (POMS): Tension-Anxiety Subscale	0.30; -0.31; 0.15; -0.26; 0.31; -0.18	—
PRIMARY Change From Baseline in the Profile of Mood States (POMS): Depression-Dejection Subscale	0.38; -0.24; 0.50; -0.24; 0.56; -0.10	—
PRIMARY Change From Baseline in the Profile of Mood States (POMS): Anger-Hostility Subscale	0.16; -0.69; -0.04; -0.89; 0.24; -1.00	—
PRIMARY Change From Baseline in the Profile of Mood States (POMS): Vigor Subscale	0.16; 0.98; -1.34; -1.15; -3.30; -1.14	—
PRIMARY Change From Baseline in the Profile of Mood States (POMS): Fatigue Subscale	-0.14; -0.65; -0.29; -0.83; -0.58; -0.76	—
PRIMARY Change From Baseline in the Profile of Mood States (POMS): Confusion Subscale	0.14; -0.09; 0.03; -0.18; 0.10; -0.11	—
PRIMARY Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS): Total Score	1.05; 0.83; 2.28; 1.84; 1.19; 1.41	—
PRIMARY Change From Baseline in the Hamilton Anxiety Scale (HAM-A): Total Score	1.01; 0.75; 2.69; 2.16; 1.95; 1.86	—
PRIMARY Change From Baseline in the Overt Aggression Scale (Modified) (OAS-m): Aggression Total Score	0.13; 0.48; 0.82; 0.72; 2.24; 0.75	—
PRIMARY Change From Baseline in the Overt Aggression Scale (Modified) (OAS-m): Irritability Total Score	0.01; 0.01; 0.43; 0.41; 0.46; 0.35	—
PRIMARY Change From Baseline in the Overt Aggression Scale (Modified) (OAS-m): Suicidality Total Score	—	—
PRIMARY Change From Baseline in the Social Dysfunction and Aggression Scale (SDAS): Total Score	—	—
PRIMARY Change From Baseline in the Barratt Impulsiveness Scale - Version 11 (BIS-11): Total Score	0.34; -0.07; 0.45; 0.37; 1.34; 1.28	—
SECONDARY Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Total Score	0.13; 0.05; 0.10; 0.11; 0.07; 0.05	—
SECONDARY Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Negative Affect Domain Subscale	0.06; 0.01; 0.10; 0.09; 0.07; 0.03	—
SECONDARY Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Insomnia Domain Subscale	0.07; 0.12; 0.15; 0.17; 0.04; 0.10	—
SECONDARY Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Urge to Smoke Subscale	-0.60; -0.29; -1.40; -0.97; -2.17; -2.03	—
SECONDARY Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Restlessness Subscale	0.06; 0.08; 0.10; 0.11; 0.09; 0.04	—
SECONDARY Change From Baseline in the Minnesota Nicotine Withdrawal Scale (MNWS): Increased Appetite Subscale	0.14; 0.02; 0.10; 0.12; 0.11; 0.15	—
SECONDARY Number of Participants Exceeding Thresholds for the Profile of Mood States (POMS): Total Score	14; 11; 32; 35; 37; 38	—
SECONDARY Number of Participants Exceeding Thresholds for the Montgomery-Asberg Depression Rating Scale (MADRS): Total Score	2; 0; 7; 3; 8; 3	—
SECONDARY Number of Participants Exceeding Thresholds for the Hamilton Anxiety Scale (HAM-A): Total Score	0; 2; 9; 7; 12; 7	—
SECONDARY Number of Participants Exceeding Thresholds for the Overt Aggression Scale (Modified) (OAS-m): Agression Total Score	9; 6; 20; 21; 21; 23	—
SECONDARY Number of Participants Exceeding Thresholds for the Overt Aggression Scale (Modified) (OAS-m): Irritability Total Score	10; 11; 32; 34; 36; 36	—
SECONDARY Number of Participants Exceeding Thresholds for the Overt Aggression Scale (Modified) (OAS-m): Suicidality Total Score	—	—
SECONDARY Number of Participants Exceeding Thresholds for the Barratt Impulsiveness Scale - Version 11 (BIS-11): Total Score	1; 0; 1; 2; 1; 2	—
SECONDARY Number of Participants Exceeding Thresholds for the Social Dysfunction and Aggression Scale (SDAS): Total Score	2; 1	—
SECONDARY Number of Participants With Carbon Monoxide Confirmed Daily Smoking Cessation	16; 10	—
SECONDARY Number of Participants With 7-day Point Prevalence of Abstinence (Smoking Cessation)	19; 16; 23; 12; 20; 17	—
SECONDARY Change From Baseline in the Number of Cigarettes Smoked Per Day	-0.1; -0.2; -0.6; 0.0; -1.8; -0.3	—

Summary

Study objective is to compare neuropsychiatric adverse events in subjects treated with varenicline or placebo in a controlled setting where both groups are experiencing nicotine withdrawal.

Eligibility Criteria

Inclusion Criteria

smokers who smoke >10 cigarettes/day and who have at least a moderate level of addiction as measured by the Fagerstrom Test for Nicotine Dependence (score >5)

Exclusion Criteria

Any neuropsychiatric disease including depression, history of suicidal thoughts or behavior, bipolar disorder.
Any unstable medical condition

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00749944). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.